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Dose-Response in Radioimmunotherapy of Lymphoma


N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Dose-Response in Radioimmunotherapy of Lymphoma


OBJECTIVES:

Primary

- Determine the relationship between estimated absorbed dose and tumor response using
different dosimetric methodologies in patients with non-Hodgkin's lymphoma treated with
iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan.

- Determine the relationship between estimated absorbed dose and normal organ toxicity
using different dosimetric methodologies in these patients.

Secondary

- Assess the difference in the dose-response relationship between dosimetric
methodologies in these patients.

- Assess the influence of prior therapy on the dose-response relationship for hematologic
toxicity in these patients.

OUTLINE: Patients are stratified according to planned radioimmunotherapy treatment (iodine I
131 tositumomab vs yttrium Y 90 ibritumomab tiuxetan).

- Stratum 1: Patients receive dosimetric rituximab IV followed by indium In 111 (^111In)
ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission
tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT
scans between 2-24, 48-72, and 90-120 hours after ^111In ibritumomab tiuxetan
administration. Patients who have acceptable biodistribution receive therapeutic
rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between
days 7-9.

- Stratum 2: Patients receive dosimetric tositumomab IV over 60 minutes followed by
iodine I 131 (^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT
scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable
biodistribution receive therapeutic tositumomab IV over 60 minutes followed by ^131I
tositumomab IV over 20 minutes on approximately day 7.

In both strata, blood is collected at baseline to measure FLT-3 levels. All patients also
undergo a baseline PET/CT scan.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of non-Hodgkin's lymphoma

- Measurable disease by CT scan or nuclear medicine imaging

- Eligible, by standard of care criteria, for iodine I 131 tositumomab or yttrium Y 90
ibritumomab tiuxetan treatment

PATIENT CHARACTERISTICS:

- No other malignancy within the past 3 years except basal cell carcinoma or squamous
cell carcinoma of the skin or in situ carcinoma of the cervix

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No alcoholism or drug abuse within the past 2 years

- No severe emotional, behavioral, or psychiatric problems that would limit study
compliance

PRIOR CONCURRENT THERAPY:

- No concurrent participation in another investigational drug study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relationship between estimated absorbed dose and tumor response using different dosimetric methodologies

Outcome Time Frame:

July '06 to Sept '10

Safety Issue:

No

Principal Investigator

George Sgouros, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

JHOC-J0636

NCT ID:

NCT00416312

Start Date:

July 2006

Completion Date:

October 2009

Related Keywords:

  • Lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • splenic marginal zone lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • Waldenström macroglobulinemia
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • stage I adult Burkitt lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I mantle cell lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • adult grade III lymphomatoid granulomatosis
  • recurrent adult grade III lymphomatoid granulomatosis
  • primary central nervous system non-Hodgkin lymphoma
  • adult nasal type extranodal NK/T-cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410